# K052898: Iqmark EZ Stress

- Pathway: 510(k) (Traditional)
- Applicant: Brentwood Medical Technology Corp.
- Decided: Mar 28, 2006 after 165 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903644 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001492: Quinton Q-Stress, Model 000483, Quinton, Inc. (2000) Summary page 4.
- K991014: Case 8000 Exercise Testing System, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Indications for use
IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress. The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K052898
Methodology: https://510kreport.com/methodology